Home NDC 67751-244 Vicks NyQuil VapoCOOL
Product NDC 67751-244
11-digit product format 677510244
Labeler code 67751
Product ID 67751-244_5e4b3a6f-712c-23a6-e063-6294a90aa552
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Doxylamine Succinate, Dextromethorphan Hydrobromide
Dosage form TABLET, COATED
Route ORAL
Labeler Navajo Manufacturing Company Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-05-06
Substance ACETAMINOPHEN; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 325; 6.25; 10 mg/1; mg/1; mg/1
Pharmacologic classes Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Vicks NyQuil VapoCOOL
Brand name suffix COLD and FLU
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DOXYLAMINE SUCCINATE 6.25 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup V9BI9B5YI2 Internal UNII lookup 9D2RTI9KYH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2713312 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 148 of 174 · 3,464 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 67751-244-02 67751024402 1 POUCH in 1 CARTON (67751-244-02) / 2 TABLET, COATED in 1 POUCH 1 pouch 2025-05-06 No No Current 67751-244-04 67751024404 2 POUCH in 1 CARTON (67751-244-04) / 2 TABLET, COATED in 1 POUCH 2 pouch 2025-05-06 No No Current